Computer Systems 2020 - Trends in FDA Compliance and Enforcement for Regulated Computer Systems

FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.
FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.
Learn about Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
Understand “GxP” Systems
Understand 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
Learn how Data Archival plays a key role in ensuring security, integrity and compliance
Speaker:
Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe